UMIN-CTR Clinical Trial

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023475
Receipt No. R000027011
Scientific Title A Study on the Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme -A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Date of disclosure of the study information 2016/08/05
Last modified on 2020/05/08 (Ver. 5)

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Basic information
Public title A Study on the Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Acronym The Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme
Scientific Title A Study on the Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme
-A Randomized, Double-blind, Placebo-controlled, Parallel-group Study-
Scientific Title:Acronym The Effect of Food Containing Pueraria Flower Extract on Visceral Fat Area and Liver Function Enzyme
Region
Japan

Condition
Condition No (Subjects with normal liver function whose BMI are 23 or over and under 30)
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the efficacy of food containing pueraria flower extract on visceral fat area and liver function enzyme
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visceral fat area
Liver function enzyme
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Food containing pueraria flower extract
Interventions/Control_2 Food not containing pueraria flower extract
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria (1) Healthy males and females aged 20 to 64 years old.
(2) Subjects whose AST and ALT are up to 50 U/L, and gamma-GTP are up to 100 U/L(males) or 60 U/L(females).
(3) Subjects whose BMI are 23 or over and under 30.
(4) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1) Subjects who use oral medications affecting obesity, hyperlipidemia, lipid metabolism, liver function, and so on.
(2) Subjects who can't stop using supplements and/or functional foods (including Food for Specified Health Uses and/or Foods with Function Claims) affecting obesity, hyperlipidemia, lipid metabolism, liver function, and so on during test periods.
(3) Subjects who can't stop drinking from 2 days before each measurement.
(4) Subjects who contract, are under treatment for or have a history of liver disease.
(5) Subjects who contract or are under treatment for serious diseases (e.g., kidney disease, heart disease, respiratory disease, endocrine disease, and/or metabolic disorder).
(6) Subjects who have declared allergic reaction to ingredients of test foods.
(7) Subjects who are under treatment for or have a history of drug addiction and/or alcoholism.
(8) Subjects who have implanted metal in the abdominal area, as detected by computerized tomography.
(9) Subjects who have implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator).
(10) Subjects who have claustrophobia.
(11) Subjects who are shiftworker and/or midnight-shift worker.
(12) Subjects who have been diagnosed as familial hyperlipidemia.
(13) Subjects who are planning to become pregnant after informed consent for the current study, are pregnant or lactating.
(14) Subjects who are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study.
(15) Subjects who are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Kiyoshi
Middle name
Last name Nakamura
Organization HigashiKoganei Sakura Clinic
Division name Internal Medicine
Zip code 184-0011
Address 4-37-26 Higashi-cho, Koganei-shi, Tokyo
TEL 042-382-3888
Email kunitachisakura01@gmail.com

Public contact
Name of contact person
1st name Yoshika
Middle name
Last name Komori
Organization KSO Corporation
Division name Sales department
Zip code 105-0023
Address 1-9-7 Shibaura, Minato-ku, Tokyo
TEL 03-3452-7733
Homepage URL
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization TOYO SHINYAKU Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Suda Clinic institutional review board
Address 2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel 03-6205-6222
Email suda-clinic_irb@imeq.co.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 05 Day

Related information
URL releasing protocol https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000027011
Publication of results Published

Result
URL related to results and publications http://www.medicalonline.jp/journal/info?GoodsID=ef4oyoya/2017/009203/005&name=0091-0102j
Number of participants that the trial has enrolled 130
Results 
Statistically significant difference was confirmed in the Visceral fat area.
Statistically significant difference was not confirmed in the Liver function enzyme.
Results date posted
2020 Year 05 Month 08 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Males and females aged 20 to 64 years old.
Participant flow 
Enrolled(n=130)
Completed(n=125)
Analysed(n=111)
Adverse events 
No adverse events were observed that be related to test food.
Outcome measures 
Visceral fat area 
Liver function enzyme
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 08 Month 01 Day
Date of IRB
2016 Year 08 Month 08 Day
Anticipated trial start date
2016 Year 08 Month 06 Day
Last follow-up date
2016 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2020 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027011